RECRUITING

Mechanical Alignment Vs Kalipered Kinematic Alignment Total Knee Arthroplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Knee replacement surgery can be performed in one of two ways. Traditionally the goal was for the new joint to be in a neutral position with respect to the femur (thigh bone). This is called Mechanical Alignment (MA). The neutral position is different than the human knee's natural position, so MA often requires the surgeon to make additional cuts to the ligaments and other soft tissue around the knee. More recently surgeons have started to place the new joint in a position that more closely replicates the natural alignment of the human knee. This is called Kinemetic Alignment (KA). KA can be done without additional soft tissue dissection but the procedure requires a higher level of precision that can be difficult to achieve in every case. Some studies have found no difference in outcomes between MA and KA, whereas others have found KA to be superior. But these were small studies or studies that did not consider patient-rated outcomes.

Official Title

A Prospective, Randomized, Single-blinded Clinical Trial Comparing Mechanical Alignment Vs Kalipered Kinematic Alignment Total Knee Arthroplasty Using Medacta Spherika

Quick Facts

Study Start:2024-08-01
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06617871

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 79 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient undergoing primary TKA with a medially-stabilized SpheriKA knee system
  2. * Able to read and understand consent form and PRO instruments and willing to return for follow up visits
  1. * Varus or Valgus malalignment \>15 degrees to mechanical axis
  2. * Flexion contracture \>15 degrees or flexion \<90 degrees
  3. * BMI \>40
  4. * Revision TKA or other prior knee surgery other than arthroscopy or arthroscopic-assisted ligament reconstruction
  5. * Diagnosis or history of any of the following
  6. * inflammatory arthritis
  7. * infection in study knee
  8. * chronic pain
  9. * chronic opioid use
  10. * metabolic musculoskeletal disorder other than osteopenia/osteoporosis
  11. * Patients receiving workers' compensation for study condition
  12. * Patients who cannot complete questionnaires in English
  13. * Patients with comorbidities preventing surgery
  14. * Patients who are not able to provide informed consent

Contacts and Locations

Study Contact

Melissa Shauver, MPH
CONTACT
312-472-6024
melissa.shauver@northwestern.edu
Megan VanDyke, BSN
CONTACT
312-472-3445
megan.vandyke@nm.org

Principal Investigator

Adam Edelstein, MD
PRINCIPAL_INVESTIGATOR
Assistant Professor of Orthopaedic Surgery

Study Locations (Sites)

Northwestern Medicine
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Adam Edelstein, MD, PRINCIPAL_INVESTIGATOR, Assistant Professor of Orthopaedic Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • randomized trial
  • knee arthroplasty

Additional Relevant MeSH Terms

  • Knee Osteoarthritis
  • Knee Arthropathy